U.S. patent number 9,259,220 [Application Number 14/581,293] was granted by the patent office on 2016-02-16 for methods and apparatus for fixing sheet-like materials to a target tissue.
This patent grant is currently assigned to Rotation Medical, Inc.. The grantee listed for this patent is Rotation Medical, Inc.. Invention is credited to Charles L. Euteneuer, Diane M. Feehan, Duane Frion, Rebecca McCarville, Nathaniel Zenz-Olson.
United States Patent |
9,259,220 |
Euteneuer , et al. |
February 16, 2016 |
Methods and apparatus for fixing sheet-like materials to a target
tissue
Abstract
A staple for attaching a sheet-like implant to tissue or bone
may include first and second arms, and first and second flukes. In
some embodiments, the first arm has a proximal end and a distal
end, and the second arm has a proximal end and a distal end. A
bridge extends from the proximal end of the first arm to the
proximal end of the second arm. The first fluke has a proximal end
abutting the distal end of the first arm, and the first fluke
extends distally from the first arm. The first fluke has a lateral
extent larger than a lateral extent of the first arm and is mounted
eccentrically thereto. The first fluke includes a proximal surface
projecting at an outward angle in a proximal direction away from
the distal end of the first arm to engage the tissue or bone when
inserted therein. The second fluke has similar features. This
arrangement causes the first and second flukes to rotate in
response to a pullout force on the bridge. Methods for attaching a
sheet-like implant to a target tissue are also disclosed.
Inventors: |
Euteneuer; Charles L. (St.
Michael, MN), McCarville; Rebecca (Spring Park, MN),
Frion; Duane (Brooklyn Center, MN), Zenz-Olson;
Nathaniel (Blaine, MN), Feehan; Diane M. (Corcoran,
MN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Rotation Medical, Inc. |
Plymouth |
MN |
US |
|
|
Assignee: |
Rotation Medical, Inc.
(Plymouth, MN)
|
Family
ID: |
42370951 |
Appl.
No.: |
14/581,293 |
Filed: |
December 23, 2014 |
Prior Publication Data
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|
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Document
Identifier |
Publication Date |
|
US 20150112370 A1 |
Apr 23, 2015 |
|
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
14182723 |
Feb 18, 2014 |
8920464 |
|
|
|
12794540 |
Mar 11, 2014 |
8668718 |
|
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|
61313051 |
Mar 11, 2010 |
|
|
|
|
61253800 |
Oct 21, 2009 |
|
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|
61184198 |
Jun 4, 2009 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/0063 (20130101); A61F 2/08 (20130101); A61F
2/30749 (20130101); A61B 17/064 (20130101); A61B
17/0644 (20130101); A61B 17/068 (20130101); A61B
17/0682 (20130101); A61B 17/0642 (20130101); A61B
2017/00004 (20130101); A61B 17/0491 (20130101); A61B
2017/0645 (20130101); A61B 2017/0046 (20130101); A61B
17/0643 (20130101); A61F 2220/0016 (20130101); A61B
2017/00862 (20130101) |
Current International
Class: |
A61B
17/08 (20060101); A61B 17/064 (20060101); A61B
17/068 (20060101); A61F 2/00 (20060101); A61F
2/08 (20060101); A61B 17/04 (20060101); A61B
17/00 (20060101) |
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|
Primary Examiner: Miles; Jonathan W
Attorney, Agent or Firm: Seager, Tufte & Wickhem,
LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No.
14/182,723, filed on Feb. 18, 2014, which is a continuation of U.S.
application Ser. No. 12/794,540 filed Jun. 4, 2010, which claims
the benefit of U.S. Provisional Patent Application Ser. No.
61/313,051 Mar. 11, 2010; U.S. Provisional Patent Application Ser.
No. 61/253,800 filed on Oct. 21, 2009; and U.S. Provisional Patent
Application No. 61/184,198 file on Jun. 4, 2009, the disclosures of
each incorporated herein by reference.
INCORPORATION BY REFERENCE
The present application is related to U.S. patent application Ser.
No. 14/182,723, entitled "Methods and Apparatus for Fixing
Sheet-Like Materials to a Target Tissue", filed on Feb. 18, 2014;
U.S. patent application Ser. No. 14/172,601, entitled "Methods an
Apparatus for Fixing Sheet-Like Materials to a Target Tissue",
filed Feb. 4, 2014; U.S. patent application Ser. No. 13/889,675,
entitled "Methods and Apparatus for Fixing Sheet-like Materials to
a Target Tissue", filed May 8, 2013; U.S. patent application Ser.
No. 12/794,540, entitled "Methods and Apparatus for Fixing
Sheet-Like Materials to a Target Tissue", filed Jun. 4, 2010, the
disclosures of each incorporated herein by reference.
All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
Claims
What is claimed is:
1. A staple for attaching a sheet-like implant to tissue or bone
comprising: a first arm having a proximal end and a distal end; a
second arm having a proximal end and a distal end; a bridge
extending from the proximal end of the first arm to the proximal
end of the second arm; a first fluke extending distally from the
distal end of the first arm to a first pointed tip, the first fluke
arranged eccentrically to the distal end of the first arm with a
first barb extending laterally outward beyond the first arm, the
first barb including a proximal surface facing the first arm and
projecting at an outward angle in a proximal direction away from
the distal end of the first arm to engage the tissue or bone when
inserted therein, thereby causing the first fluke to rotate in
response to a pullout force on the bridge; and a second fluke
extending distally from the distal end of the second arm to a
second pointed tip, the second fluke arranged eccentrically to the
distal end of the second arm with a second barb extending laterally
outward beyond the second arm, the second barb including a proximal
surface facing the second arm and projecting at an outward angle in
a proximal direction away from the distal end of the second arm to
engage the tissue or bone when inserted therein, thereby causing
the second fluke to rotate in response to a pullout force on the
bridge; wherein the proximalmost surface of the first barb extends
at an oblique angle to the proximalmost surface of the second
barb.
2. The staple of claim 1, wherein: the first fluke includes a
passage extending distally from the proximal surface of the first
barb; and the second fluke includes a passage extending distally
from the proximal surface of the second barb.
3. The staple of claim 2, wherein the passage of the first fluke is
located laterally outward of the first arm and the passage of the
second fluke is located laterally outward of the second arm.
4. The staple of claim 2, wherein each passage of the first and the
second flukes is sized to receive a first stake and a second stake,
respectively, of a staple delivery device therein.
5. The staple of claim 4, wherein the proximal surface of the first
barb is configured to engage the first stake and the proximal
surface of the second barb is configured to engage the second stake
to receive pushing forces for inserting the staple into the
tissue.
6. The staple of claim 2, wherein: the passage of the first fluke
extends from a proximal opening on the proximal surface of the
first barb to a distal opening on a distal surface of the first
fluke; and the passage of the second fluke extends from a proximal
opening on the proximal surface of the second barb to a distal
opening on a distal surface of the second fluke.
7. The staple of claim 6, wherein: a portion of the first fluke
extends distal of the distal opening of the passage of the first
fluke; and a portion of the second fluke extends distal of the
distal opening of the passage of the second fluke.
8. The staple of claim 1, wherein at least a portion of the first
and second arms is flexible to allow flexing of the first and
second flukes relative thereto to achieve rotational engagement of
each fluke to the tissue or bone.
9. The staple of claim 1, wherein the first arm, the second arm,
the bridge, the first fluke, and the second fluke are integrally
formed of a polymeric material.
10. The staple of claim 9, wherein the polymeric material is
bioresorbable.
11. The staple of claim 1, wherein the first barb includes a notch
dividing the first barb into first and second portions.
12. The staple of claim 11, wherein the second barb includes a
notch dividing the second barb into first and second portions.
13. A staple for attaching a sheet-like implant to tissue or bone
comprising: a first arm, having a proximal end and a distal end; a
second arm having a proximal end and a distal end; a bridge
extending from the proximal end of the first arm to the proximal
end of the second arm; a first fluke extending distally from the
distal end of the first arm to a first pointed tip, the first fluke
including a first barb extending laterally outward beyond the first
arm, the first barb including a proximal surface projecting at an
outward angle in a proximal direction away from the distal end of
the first arm to engage the tissue or bone when inserted therein,
thereby causing the first fluke to rotate in response to a pullout
force on the bridge, the first fluke further including a passage
extending through the first fluke, the passage of the first fluke
extends from a proximal opening on the proximal surface of the
first barb to a distal opening on a distal surface of the first
fluke, the first pointed tip of the first fluke located laterally
outward of the distal opening of the passage through the first
fluke; and a second fluke extending distally from the distal end of
the second arm to a second pointed tip, the second fluke including
a second barb extending laterally outward beyond the second arm,
the second barb including a proximal surface projecting at an
outward angle in a proximal direction away from the distal end of
the second arm to engage the tissue or bone when inserted therein,
thereby causing the second fluke to rotate in response to a pullout
force on the bridge, the second fluke further including a passage
extending through the second fluke, the passage of the second fluke
extends from a proximal opening on the proximal surface of the
second barb to a distal opening on a distal surface of the second
fluke, the second pointed tip of the second fluke located laterally
outward of the distal opening of the passage through the second
fluke.
14. The staple of claim 13, wherein the passage of the first fluke
is located laterally outward of the first arm and the passage of
the second fluke is located laterally outward of the second
arm.
15. The staple of claim 13, wherein each passage of the first and
the second flukes is sized to receive a first stake and a second
stake, respectively, of a staple delivery device therein.
16. The staple of claim 15, wherein the proximal surface of the
first barb is configured to engage the first stake and the proximal
surface of the second barb is configured to engage the second stake
to receive pushing forces for inserting the staple into the
tissue.
17. The staple of claim 13, wherein a lateral extent of the first
fluke is greater than a lateral extent of the first arm and a
lateral extent of the second fluke is greater than a lateral extent
of the second arm.
18. The staple of claim 13, wherein the first fluke is devoid of
barbs or projections extending toward the second fluke, and the
second fluke is devoid of barbs or projections extending toward the
first fluke.
19. A staple for attaching a sheet-like implant to tissue or bone
comprising: first and second arms each having a proximal end and a
distal end, the first and second arms extending parallel to a
longitudinal axis of the staple; a bridge extending from the
proximal end of the first arm to the proximal end of the second
arm; first and second flukes extending distally from the distal end
of each of the first and second arms, respectively, wherein each
fluke has a distal pointed tip and is arranged eccentrically to the
distal end of its respective arm with a barb extending laterally
outward beyond its respective arm, each barb including a
proximalmost surface projecting at an outward angle in a proximal
direction away from the distal end of its respective arm in a
direction non-perpendicular to the longitudinal axis to engage the
tissue or bone when inserted therein, thereby causing the fluke to
rotate in response to a pullout force on the bridge.
20. The staple of claim 19, wherein the proximal surface of each
barb faces its respective arm.
Description
FIELD OF THE INVENTION
The present invention relates generally to orthopedic medicine and
surgery. More particularly, the present invention relates to
methods and apparatus for delivery and fixation of sheet-like
materials, such as for treating articulating joints.
BACKGROUND OF THE INVENTION
The glenohumeral joint of the shoulder is found where the head of
the humerus mates with a shallow depression in the scapula. This
shallow depression is known as the glenoid fossa. Six muscles
extend between the humerus and scapula and actuate the glenohumeral
joint. These six muscles include the deltoid, the teres major, and
the four rotator cuff muscles. As disclosed by Ball et al. in U.S.
Patent Publication No. US 2008/0188936 A1 and as illustrated in
FIG. 1 the rotator cuff muscles are a complex of four muscles.
These four muscles are the supraspinatus, the infraspinatus, the
subscapularis, and the teres minor. The centering and stabilizing
roles played by the rotator cuff muscles are critical to the proper
function of the shoulder. The rotator cuff muscles provide a wide
variety of moments to rotate the humerus and to oppose unwanted
components of the deltoid and pectoralis muscle forces.
The four muscles of the rotator cuff arise from the scapula 12. The
distal tendons of the rotator cuff muscles splay out and
interdigitate to form a common continuous insertion on the humerus
14. The subscapularis 16 arises from the anterior aspect of the
scapula 12 and attaches over much of the lesser tuberosity of the
humerous. The supraspinatus muscle 18 arises from the supraspinatus
fossa of the posterior scapula, passes beneath the acromion and the
acromioclavicular joint, and attaches to the superior aspect of the
greater tuberosity 11. The infraspinatus muscle 13 arises from the
infraspinous fossa of the posterior scapula and attaches to the
posterolateral aspect of the greater tuberosity 11. The teres minor
15 arises from the lower lateral aspect of the scapula 12 and
attaches to the lower aspect of the greater tuberosity 11.
The mechanics of the rotator cuff muscles 10 are complex. The
rotator cuff muscles 10 rotate the humerus 14 with respect to the
scapula 12, compress the humeral head 17 into the glenoid fossa
providing a critical stabilizing mechanism to the shoulder (known
as concavity compression), and provide muscular balance. The
supraspinatus and infraspinatus provide 45 percent of abduction and
90 percent of external rotation strength. The supraspinatus and
deltoid muscles are equally responsible for producing torque about
the shoulder joint in the functional planes of motion.
The rotator cuff muscles 10 are critical elements of this shoulder
muscle balance equation. The human shoulder has no fixed axis. In a
specified position, activation of a muscle creates a unique set of
rotational moments. For example, the anterior deltoid can exert
moments in forward elevation, internal rotation, and cross-body
movement. If forward elevation is to occur without rotation, the
cross-body and internal rotation moments of this muscle must be
neutralized by other muscles, such as the posterior deltoid and
infraspinatus. The timing and magnitude of these balancing muscle
effects must be precisely coordinated to avoid unwanted directions
of humeral motion. Thus the simplified view of muscles as isolated
motors, or as members of force couples must give way to an
understanding that all shoulder muscles function together in a
precisely coordinated way--opposing muscles canceling out undesired
elements leaving only the net torque necessary to produce the
desired action. Injury to any of these soft tissues can greatly
inhibit ranges and types of motion of the arm.
With its complexity, range of motion and extensive use, a fairly
common soft tissue injury is damage to the rotator cuff or rotator
cuff tendons. Damage to the rotator cuff is a potentially serious
medical condition that may occur during hyperextension, from an
acute traumatic tear or from overuse of the joint. With its
critical role in abduction, rotational strength and torque
production, the most common injury associated with the rotator cuff
region is a strain or tear involving the supraspinatus tendon. A
tear in the supraspinitus tendon 19 is schematically depicted in
FIG. 2. A tear at the insertion site of the tendon with the
humerus, may result in the detachment of the tendon from the bone.
This detachment may be partial or full, depending upon the severity
of the injury. Additionally, the strain or tear can occur within
the tendon itself. Injuries to the supraspinatus tendon 19 and
recognized modalities for treatment are defined by the type and
degree of tear. The first type of tear is a full thickness tear as
also depicted in FIG. 2, which as the term indicates is a tear that
extends through the thickness of the supraspinatus tendon
regardless of whether it is completely torn laterally. The second
type of tear is a partial thickness tear which is further
classified based on how much of the thickness is torn, whether it
is greater or less than 50% of the thickness.
The accepted treatment for a full thickness tear or a partial
thickness tear greater than 50% includes reconnecting the torn
tendon via sutures. For the partial thickness tears greater than
50%, the tear is completed to a full thickness tear by cutting the
tendon prior to reconnection. In contrast to the treatment of a
full thickness tear or a partial thickness tear of greater than
50%, the treatment for a partial thickness tear less than 50%
usually involves physical cessation from use of the tendon, i.e.,
rest. Specific exercises can also be prescribed to strengthen and
loosen the shoulder area. In many instances, the shoulder does not
heal and the partial thickness tear can be the source of chronic
pain and stiffness. Further, the pain and stiffness may cause
restricted use of the limb which tends to result in further
degeneration or atrophy in the shoulder. Surgical intervention may
be required for a partial thickness tear of less than 50%, however,
current treatment interventions do not include repair of the
tendon, rather the surgical procedure is directed to arthroscopic
removal of bone to relieve points of impingement or create a larger
tunnel between the tendon and bone that is believed to be causing
tendon damage. As part of the treatment, degenerated tendon may
also be removed using a debridement procedure in which tendon
material is ablated. Again, the tendon partial tear is not
repaired. Several authors have reported satisfactory early post
operative results from these procedures, but over time recurrent
symptoms have been noted. In the event of recurrent symptoms, many
times a patient will "live with the pain". This may result in less
use of the arm and shoulder which further causes degeneration of
the tendon and may lead to more extensive damage. A tendon repair
would then need to be done in a later procedure if the prescribed
treatment for partial tear was unsuccessful in relieving pain and
stiffness or over time the tear propagated through injury or
degeneration to a full thickness tear or a partial thickness tear
greater than 50% with attendant pain and debilitation. A subsequent
later procedure would include the more drastic procedure of
completing the tear to full thickness and suturing the ends of the
tendon back together. This procedure requires extensive
rehabilitation, has relatively high failure rates and subjects the
patient who first presented and was treated with a partial
thickness tear less than 50% to a second surgical procedure.
As described above, adequate treatments do not currently exist for
repairing a partial thickness tear of less than 50% in the
supraspinatus tendon. Current procedures attempt to alleviate
impingement or make room for movement of the tendon to prevent
further damage and relieve discomfort but do not repair or
strengthen the tendon. Use of the still damaged tendon can lead to
further damage or injury. Prior damage may result in degeneration
that requires a second more drastic procedure to repair the tendon.
Further, if the prior procedure was only partially successful in
relieving pain and discomfort, a response may be to use the
shoulder less which leads to degeneration and increased likelihood
of further injury along with the need for more drastic surgery.
There is a large need for surgical techniques and systems to treat
partial thickness tears of less than 50% and prevent future tendon
damage by strengthening or repairing the native tendon having the
partial thickness tear.
SUMMARY OF THE INVENTION
In accordance with aspects of the present invention, a staple for
attaching a sheet-like implant to tissue or bone is disclosed. In
some embodiments, the staple includes first and second arms, and
first and second flukes. The first arm has a proximal end and a
distal end, and the second arm has a proximal end and a distal end.
A bridge extends from the proximal end of the first arm to the
proximal end of the second arm. The first fluke has a proximal end
abutting the distal end of the first arm, and the first fluke
extends distally from the first arm. The first fluke has a lateral
extent larger than a lateral extent of the first arm and is mounted
eccentrically thereto. The first fluke includes a proximal surface
projecting at an outward angle in a proximal direction away from
the distal end of the first arm to engage the tissue or bone when
inserted therein. This arrangement causes the first fluke to rotate
in response to a pullout force on the bridge. The second fluke has
a proximal end abutting the distal end of the second arm and
extends distally. The second fluke has a lateral extent larger than
the lateral extent of the second arm and is mounted eccentrically
thereto. The second fluke includes a proximal surface projecting at
an outward angle in a proximal direction and away from the second
arm near the proximal end of the second fluke to engage the tissue
or bone when inserted therein. This arrangement causes the second
fluke to rotate in response to a pullout force on the bridge.
In some embodiments of the invention, the lateral extent of each of
the flukes is at least about three times the lateral extent of the
arm adjacent thereto. In some embodiments, the lateral extent of
the first arm and the second arm is about 0.3 mm. to about 3.0
mm.
Each of the first fluke and the second fluke may include a lumen
extending from the proximal end to the distal end thereof. The
lumen may be spaced laterally from the respective arm mounted
thereto. In some embodiments, each lumen of the first and the
second fluke is sized to receive a first stake and a second stake,
respectively, of a staple delivery device therethrough. The first
fluke may include a proximal surface that engages the first stake
and the second fluke may include a proximal surface that engages
the second stake to receive pushing forces for inserting the staple
into the tissue.
In some embodiments, at least a portion of each of the lengths of
the first and the second arms is flexible to allow flexing of the
first and second flukes relative thereto. This arrangement is
designed to achieve rotational engagement of each fluke to the
tissue or bone.
According to aspects of the invention, the first arm, second arm,
first fluke, second fluke, proximal surfaces and bridge may be
integrally formed of a polymeric material. In some embodiments, the
polymeric material is bioresorbable.
According to other aspects of the invention, methods for attaching
a sheet-like implant to a target tissue are disclosed. In some
embodiments, the method includes the steps of providing a staple,
creating first and second pilot holes in the target tissue, and
advancing parts of the staple into the pilot holes. In these
embodiments, the staple includes first and second arms, each having
proximal and distal ends. A bridge extends from the proximal end of
the first arm to the proximal end of the second arm. The staple
further includes a first fluke and a second fluke. The first fluke
has a proximal end abutting the distal end of the first arm. The
first fluke also extends distally from the first arm, has a lateral
extent larger than a lateral extent of the first arm, and is
mounted eccentrically thereto. The first fluke includes a proximal
surface projecting at an outward angle in a proximal direction away
from the distal end of the first arm. The second fluke has a
proximal end abutting the distal end of the second arm. The second
fluke also extends distally from the second arm, has a lateral
extent larger than a lateral extent of the second arm, and is
mounted eccentrically thereto. The second fluke includes a proximal
surface projecting at an outward angle in a proximal direction away
from the distal end of the second arm.
In the advancing step of the above methods, the first fluke of the
staple is advanced into the first pilot hole and the second fluke
is advanced into the second pilot hole, such that the bridge
portion of the staple extends from adjacent the first pilot hole to
adjacent the second pilot hole.
In some of the inventive methods, a first force is applied to a
surface of the first fluke to produce a first moment. The first
moment causes the first fluke to rotate in a first direction so
that a first longitudinal axis of the first fluke is skewed
relative to a central axis of the first pilot hole. A second force
is also applied to a surface of the second fluke to produce a
second moment. The second moment causes the second fluke to rotate
in a second direction so that a second longitudinal axis of the
second fluke is skewed relative to a central axis of the second
pilot hole. The first moment has a first direction and the second
moment has a second direction. The first and the second forces may
be applied simultaneously. In some embodiments, the first force is
applied to the proximal surface of the first fluke at a location
that is offset from the first arm, and the second force is applied
to the proximal surface of the second fluke at a location that is
offset from the second arm.
In some of the above embodiments, the application of the first
force and the second force place the first arm, the second arm, and
the bridge in tension relative to the tissue. This aids in staple
retention as the first and the second fluke engage the tissue. In
some embodiments, the first arm provides a first reaction force in
response to the first force and the second force. The first
reaction force has a first reaction direction that is generally
opposite the direction of the first force. In these embodiments,
the first reaction direction is offset from the direction of the
first force. In some of the above embodiments, the second arm
provides a second reaction force in response to the first force and
the second force. The second reaction force has a second reaction
direction that is generally opposite the direction of the second
force. In these embodiments, the second reaction direction is
offset from the direction of the second force.
In some embodiments, a force is applied to the first and second
fluke to place the first arm, the second arm, and the bridge in
tension relative to the tissue to aid in staple retention as the
first and the second fluke engage the tissue. In some embodiments,
releasing the force applied to the first and second flukes allows
the tissue to apply a force against the staple. This causes the
first and second flukes to further engage the tissue to inhibit
staple pullout. The force of the tissue against the staple may
cause the first fluke to rotate in a first direction so that a
first longitudinal axis of the first fluke is skewed relative to a
central axis of the first pilot hole. It may also cause the second
fluke to rotate in a second direction so that a second longitudinal
axis of the second fluke is skewed relative to a central axis of
the second pilot hole. In some embodiments, the first and second
directions are opposite.
In some embodiments, at least one of the first and the second pilot
holes is created in the sheet-like implant and the target tissue.
At least a part of the bridge portion of the staple will contact
the sheet-like implant after the first and the second flukes of the
staple have been advanced into the first and the second pilot
holes.
Additional aspects of the present invention will become clear after
review of the Detailed Description with reference to the following
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a simplified perspective view of the human rotator cuff
and associated anatomical structure.
FIG. 2 is a schematic depiction of a full thickness tear in the
supraspinatus tendon of the rotator cuff of FIG. 1.
FIG. 3 is a stylized anterior view of a patient with a shoulder of
patient being shown in cross-section for purposes of
illustration.
FIG. 4 is a stylized anterior view of a shoulder including a
humerus and a scapula. The head of the humerus is shown mating with
the glenoid fossa of the scapula at a glenohumeral joint and a
sheet-like material is fixed to the tendon.
FIG. 5 is a stylized perspective view illustrating an exemplary
procedure for treating a shoulder of a patient.
FIG. 6 is a stylized perspective view of a shoulder including a
supraspinatus having a distal tendon with a sheet-like material
fixed thereto. A proximal end of the supraspinatus is fixed to the
scapula and the distal tendon of the supraspinatus is fixed to the
humerus.
FIG. 7A, FIG. 7B, and FIG. 7C are multiple plan views illustrating
an exemplary staple in accordance with the present detailed
description.
FIG. 8 is a perspective view further illustrating the staple shown
in the previous Figure.
FIG. 9 is a perspective view showing a staple push rod that may be
used in conjunction with the staple shown in the previous
Figure.
FIG. 10A and FIG. 10B illustrate multiple plan views of an
exemplary fixation tool in accordance with the present detailed
description.
FIG. 11A is a further enlarged partial cross-sectional view of a
distal portion of the fixation tool shaft shown in the previous
Figure.
FIG. 11B is an additional partial cross-sectional view showing a
staple carried by a staple push rod and a fixation tool shaft
disposed about the staple push rod.
FIG. 12A through FIG. 12C are a sequence of plan views illustrating
an exemplary method and apparatus in accordance with the present
detailed description.
FIG. 13A, FIG. 13B, FIG. 13C and FIG. 13D are multiview projections
illustrating a fixation tool shaft shown in the previous
Figures.
FIG. 14 is an enlarged axial view of the fixation tool shaft shown
in the previous Figure.
FIG. 15 is an additional enlarged axial view of the fixation tool
shaft shown in the previous Figure.
FIG. 16 is an exploded isometric view of an exemplary fixation tool
in accordance with this detailed description.
DETAILED DESCRIPTION OF THE INVENTION
The following detailed description should be read with reference to
the drawings in which similar elements in different drawings are
numbered the same. The drawings, which are not necessarily to
scale, depict illustrative embodiments and are not intended to
limit the scope of the invention.
As used herein, the term "tissue" refers to soft tissue, such as a
tendon, and/or bone tissue, depending on the context in which it is
used.
FIG. 3 is a stylized anterior view of a patient 20. For purposes of
illustration, a shoulder 22 of patient 20 is shown in cross-section
in FIG. 3. Shoulder 22 includes a humerus 14 and a scapula 12. In
FIG. 3, a head 24 of humerus 14 can be seen mating with a glenoid
fossa of scapula 12 at a glenohumeral joint With reference to FIG.
3, it will be appreciated that the glenoid fossa comprises a
shallow depression in scapula 12. The movement of humerus 14
relative to scapula 12 is controlled by a number of muscles
including: the deltoid, the supraspinatus, the infraspinatus, the
subscapularis, and the teres minor. For purposes of illustration,
only the supraspinatus 26 is shown in FIG. 3.
With reference to FIG. 3, it will be appreciated that a distal
tendon 2 of the supraspinatus 26 meets humerus 14 at an insertion
point. Scapula 12 of shoulder 22 includes an acromium 32. In FIG.
3, a subacromial bursa 34 is shown extending between acromium 32 of
scapula 12 and head 24 of humerus 14. In FIG. 3, subacromial bursa
34 is shown overlaying supraspinatus 26. Subacromial bursa 34 is
one of the hundreds of bursae found the human body. Each bursa
comprises a fluid filled sac. The presence of these bursae in the
body reduces friction between bodily tissues. Injury and/or
infection of the bursa can cause it to become inflamed. This
condition is sometimes referred to as bursitis.
The exemplary methods and apparatus described herein may be used to
fix tendon repair implants to various target tissues. For example,
a tendon repair implant may be fixed to one or more tendons
associated with an articulating joint, such as the glenohumeral
joint. The tendons to be treated may be torn, partially torn, have
internal micro-tears, be untorn, and/or be thinned due to age,
injury or overuse. Applicants believe that the methods and
apparatus of the present application and related devices may
provide very beneficial therapeutic effect on a patient
experiencing joint pain believed to be caused by partial thickness
tears and/or internal microtears. By applying a tendon repair
implant early before a full tear or other injury develops, the
implant may cause the tendon to thicken and/or at least partially
repair itself, thereby avoiding more extensive joint damage, pain,
and the need for more extensive joint repair surgery.
FIG. 4 is a stylized anterior view of a shoulder 22 including a
humerus 14 and a scapula 12. In FIG. 4, a head 24 of humerus 14 is
shown mating with a glenoid fossa of scapula 12 at a glenohumeral
joint. A supraspinatus 26 is also shown in FIG. 4. This muscle
(along with others) control the movement of humerus 14 relative to
scapula 12. A distal tendon 28 of supraspinatus 26 meets humerus 14
at an insertion point 30.
In the embodiment of FIG. 4, distal tendon 28 includes a first
damaged portion 36. A number of loose tendon fibers 40 in first
damaged portion 36 are visible in FIG. 4. First damaged portion 36
includes a first tear 42 extending partially through distal tendon
28. First tear 42 may therefore be referred to as a partial
thickness tear. With reference to FIG. 4, it will be appreciated
that first tear 42 begins on the side of distal tendon 28 facing
the subacromial bursa (shown in the previous Figure) and ends
midway through distal tendon 28. Accordingly, first tear 42 may be
referred to as a bursal side tear.
With reference to FIG. 4, it will be appreciated that distal tendon
28 includes a second damaged portion 38 located near insertion
point 30. In the embodiment of FIG. 4, second damaged portion 38 of
distal tendon 28 has become frayed and a number of loose tendon
fibers 40 are visible in FIG. 4. Second damaged portion 38 of
distal tendon 28 includes second tear 44. With reference to FIG. 4,
it will be appreciated that second tear 44 begins on the side of
distal tendon 28 facing the humerus 14. Accordingly, second damaged
portion 38 may be referred to as an articular side tear.
In the embodiment of FIG. 4, a sheet-like implant 50 has been
placed over the bursal side of distal tendon 28. With reference to
FIG. 4, it will be appreciated that sheet-like implant 50 extends
over insertion point 30, first tear 42 and second tear 44. Some
useful methods in accordance with this detailed description may
include placing a tendon repair implant on the bursal side of a
tendon regardless of whether the tears being treated are on the
bursal side, articular side or within the tendon. In some cases the
exact location and nature of the tears being treated may be
unknown. A tendon repair implant may be applied to the bursal side
of a tendon to treat shoulder pain that is most likely caused by
one or more partial thickness tears in the tendon. In the
embodiment of FIG. 4, sheet-like implant 50 is fixed to distal
tendon 28 and to humerus 14 by a plurality of staples 100 as
described herein in detail.
FIG. 5 is a stylized perspective view illustrating an exemplary
procedure for treating a shoulder 22 of a patient 20. The procedure
illustrated in FIG. 5 may include, for example, fixing tendon
repair implants to one or more tendons of shoulder 22. The tendons
treated may be torn, partially torn, have internal micro-tears, be
untorn, and/or be thinned due to age, injury or overuse.
Shoulder 22 of FIG. 5 has been inflated to create a cavity therein.
In the exemplary embodiment of FIG. 5A, a fluid supply 52 is
pumping a continuous flow of saline into the cavity. This flow of
saline exits the cavity via a fluid drain 54. A camera 56 provides
images from inside the cavity. The images provided by camera 56 may
be viewed on a display 58.
Camera 56 may be used to visually inspect the tendons of shoulder
22 for damage. A tendon repair implant in accordance with this
disclosure may be fixed to a bursal surface of the tendon
regardless of whether there are visible signs of tendon damage.
Applicants believe that the methods and apparatus of the present
application and related devices may provide very beneficial
therapeutic effect on a patient experiencing joint pain believed to
be caused by internal microtears, but having no clear signs of
tendon tears. By applying a tendon repair implant early before a
full tear or other injury develops, the implant may cause the
tendon to thicken and/or at least partially repair itself, thereby
avoiding more extensive joint damage, pain, and the need for more
extensive joint repair surgery.
A delivery system 60 can be seen extending from shoulder 22 in FIG.
5. Delivery system 60 comprises a sheath that is fixed to a handle.
The sheath defines a lumen and a distal opening fluidly
communicating the lumen. In the embodiment of FIG. 5, the distal
opening of the sheath has been placed in fluid communication with
the cavity created in shoulder 22.
A tendon repair implant is at least partially disposed in the lumen
defined by the sheath of delivery system 60. Delivery system 60 can
be used to place the tendon repair implant inside shoulder 22.
Delivery system 60 can also be used to hold the tendon repair
implant against the tendon. In some embodiments, the tendon repair
implant is folded into a compact configuration when inside the
lumen of the sheath. When this is the case, delivery system 60 may
be used to unfold the tendon repair implant into an expanded
shape.
The tendon repair implant may be fixed to the tendon while it is
held against the tendon by delivery system 60. Various attachment
elements may be used to fix the tendon repair implant to the
tendon. Examples of attachment elements that may be suitable in
some applications include sutures, tissue anchors, bone anchors,
and staples. In the exemplary embodiment of FIG. 5, the shaft of a
fixation tool 70 is shown extending into shoulder 22. In one
exemplary embodiment, fixation tool 70 is capable of fixing the
tendon repair implant to the tendon with one or more staples while
the tendon repair implant is held against the tendon by delivery
system 60.
FIG. 6 is a stylized perspective view of a shoulder 22 including a
supraspinatus 26 having a distal tendon 28. With reference to FIG.
6, it will be appreciated that a tendon repair implant 50 has been
fixed to a surface of distal tendon 28. Tendon repair implant 50
may comprise, for example, various sheet-like structures without
deviating from the spirit and scope of the present detailed
description. In some useful embodiments, the sheet-like structure
may comprise a plurality of fibers. The fibers may be interlinked
with one another. When this is the case, the sheet-like structure
may comprise a plurality of apertures comprising the interstitial
spaces between fibers. Various processes may be used to interlink
the fibers with one another. Examples of processes that may be
suitable in some applications including weaving, knitting, and
braiding. In some embodiment, the sheet-like structure may comprise
a laminate including multiple layers of film with each layer of
film defining a plurality of micro-machined or formed holes. The
sheet-like structure of the tendon repair implant may also comprise
a plurality of electro-spun nanofiber filaments forming a composite
sheet. Additionally, the sheet-like structure may comprise a
synthetic sponge material that defines a plurality of pores. The
sheet-like structure may also comprise a reticulated foam material.
Reticulated foam materials that may be suitable in some
applications are available from Biomerix Corporation of Freemont,
Calif. which identifies these materials using the trademark
BIOMATERIAL.TM..
Various attachment elements may be used to fix tendon repair
implant 50 to distal tendon 28 without deviating from the spirit
and scope of this detailed description. Examples of attachment
elements that may be suitable in some applications include sutures,
tissue anchors, bone anchors, and staples. In the exemplary
embodiment of FIG. 6, a plurality of staples 100 are fixing tendon
repair implant 50 to distal tendon 28. In some exemplary methods, a
plurality of staples 100 may be applied using a fixation tool. The
fixation tool may then be withdrawn from the body of the patient.
Distal tendon 28 meets humerus 14 at an insertion point 30. With
reference to FIG. 6, it will be appreciated that sheet-like implant
50 extends over insertion point 30. Tendon repair implant may be
applied to distal tendon 28, for example, using the procedure
illustrated in the previous Figure.
FIG. 7A, FIG. 7B, and FIG. 7C are multiple plan views illustrating
an exemplary staple 100 in accordance with the present detailed
description. FIG. 7A, FIG. 7B, and FIG. 7C may be collectively
referred to as FIG. 7. A proximal direction is illustrated with an
arrow P in FIG. 7. A distal direction is illustrated with a second
arrow D in FIG. 7.
Staple 100 comprises a first arm 102A, a second arm 102B, and a
bridge 104 extending from the proximal end of first arm 102A to the
proximal end of second arm 102B. The distal end of first arm 102A
abuts the proximal end of a first fluke 106A. Similarly, the distal
end of second arm 102B abuts the proximal end of a second fluke
106B. In FIG. 7, first fluke 106A and second fluke 106B are shown
extending distally from first arm 102A and second arm 102B,
respectively. With reference to FIG. 7, it will be appreciated that
first fluke 106A has a lateral extent that is larger than a lateral
extent of first arm 102A. First fluke 106A is mounted eccentrically
to first arm 102A in the embodiment of FIG. 7. Second fluke 106B is
mounted eccentrically to second arm 102B and second fluke 106B has
a lateral extent that is larger than a lateral extent of second arm
102B. First fluke 106A includes a first proximal surface 108A
projecting at an outward angle in a proximal direction away from
the distal end of first arm 102A. Second fluke 106B includes a
second proximal surface 108B projecting at an outward angle in a
proximal direction away from the distal end of second arm 102B.
With reference to FIG. 7A, it will be appreciated that first fluke
106A includes a first point 120A and a first barb 122A. Second
fluke 106B includes a second point 120B and a second barb 122B. In
FIG. 7, first point 120A and second point 120B are shown generally
pointing in the distal direction indicated by arrow D. Also in FIG.
7, first barb 122A and second barb 122B are shown generally
pointing in the proximal direction indicated by arrow P.
With reference to FIG. 7A it will be appreciated that first fluke
106A defines a first passageway 124A and second fluke 106B defines
a second passageway 124B. In the exemplary embodiment of FIG. 7,
first passageway 124A extends through first fluke 106A and second
passageway 124B extends through second fluke 106B. It will be
appreciated, however, that first passageway 124A may extend through
other portions of staple 100 in some embodiments. Similarly, second
passageway 124B may extend through other portions of staple 100 in
some embodiments. With reference to FIG. 7B it will be appreciated
that, first passageway 124A and second passageway 124B each have a
generally square cross-sectional shape. It will be appreciated,
however, that first passageway 124A and second passageway 124B may
have various cross-sectional shapes without deviating from the
spirit and scope of the present detailed description. Further, each
passageway can extend partially through the length of each fluke
rather than all the way through to provide a cavity rather than a
passageway.
With reference to FIG. 7C, it will be appreciated that first barb
122A of first fluke 106A defines a first notch 126A. In the
exemplary embodiment of FIG. 7, first notch 126A divides first barb
122A into a first sub-barb and a second sub-barb. Second barb 122B
of second fluke 106B defines a second notch 126B. In the exemplary
embodiment of FIG. 7, second notch 126B divides second barb 122B
into a first sub-barb and a second sub-barb.
FIG. 8 is a perspective view showing staple 100 shown in the
previous Figure. Staple 100 comprises a first arm 102A, a second
arm 102B, and a bridge 104 extending from the proximal end of first
arm 102A to the proximal end of second arm 102B. The distal end of
first arm 102A abuts the proximal end of a first fluke 106A. With
reference to FIG. 8 it will be appreciated that first fluke 106A
defines a first passageway 124A. In the exemplary embodiment of
FIG. 8, first passageway 124A has a generally square
cross-sectional shape. It will be appreciated, however, that first
passageway 124A may have various cross-sectional shapes without
deviating from the spirit and scope of the present detailed
description.
A second fluke 106B extends distally from second arm 102B with the
proximal end of second fluke 106B abutting the distal end of second
arm 102B. With reference to FIG. 8, it will be appreciated that
second fluke 106B has a lateral extent that is larger than a
lateral extent of second arm 102B. Second fluke 106B is mounted
eccentrically to second arm 102B in the embodiment of FIG. 8.
Similarly, first fluke 106A is mounted eccentrically to first arm
102A and first fluke 106A has a lateral extent that is larger than
a lateral extent of first arm 102A.
A proximal direction is illustrated with an arrow P in FIG. 8. A
distal direction is illustrated with a second arrow D in FIG. 8.
With reference to FIG. 8A, it will be appreciated that first fluke
106A of first arm 102A includes a first point 120A and a first barb
122A. Second fluke 106B includes a second point 120B and a second
barb 122B. In FIG. 8, first point 120A and second point 120B are
shown generally pointing in the distal direction indicated by arrow
D. Also in FIG. 8, first barb 122A and second barb 122B are shown
generally pointing in the proximal direction indicated by arrow P.
With reference to FIG. 8, it will be appreciated that first fluke
106A includes a first proximal surface 108A projecting at an
outward angle in a proximal direction away from the distal end of
first arm 102A. Second fluke 106B includes a second proximal
surface 108B projecting at an outward angle in a proximal direction
away from the distal end of second arm 102B.
FIG. 9 is a perspective view showing a staple push rod 130 that may
be used in conjunction with staple 100 shown in the previous
Figure. Staple push rod 130 includes a shaft 132 and a pair of
stakes 134 extending distally beyond a distal end of shaft 132. The
distal direction is indicated with an arrow D in FIG. 9. Stakes 134
include a first stake 134A and a second stake 134B. First stake
134A and second stake 134B form a fork 136.
In the embodiment of FIG. 9, each stake 134 has a distal portion
138 and a proximal portion 140. In some useful embodiments, each
distal portion 138 is dimensioned to extend into a passage defined
by a staple. In the embodiment of FIG. 9, each proximal portion 140
has a width larger than a width of each distal portion 138 so that
a shoulder of each proximal portion 140 contacts a proximal surface
of the staple to apply pushing forces thereto. First stake 134A
comprises a first shoulder 142A and second stake 134B comprises a
second shoulder 142B. Although depicted as a shoulder to provide
pushing force to the staple, other designs can be utilized. For
example, any larger cross section proximal portion can provide a
pushing force, such as a conical increase in profile. In the
embodiment of FIG. 9, proximal portion 140 of first stake 134A and
the proximal portion 140 of second stake 134B diverge from one
another as they extend in distal direction D away from shaft 132.
In some applications, this arrangement may cause pushing forces
applied to two flukes of a staple to have a laterally outward
component.
In FIG. 9, first stake 134A and second stake 134B are shown
assuming a substantially unstressed state. It will be appreciated
that first stake 134A and second stake 134B can be resiliently
urged to assume shapes other than the shape shown in FIG. 9. For
example, first stake 134A and second stake 134B may be urged
together so that fork 136 can be inserted into a lumen having a
diameter smaller than the distance between the distal points of
first stake 134A and second stake 134B shown in FIG. 9.
FIG. 10A and FIG. 10B illustrate multiple plan views of an
exemplary fixation tool 144 in accordance with the present detailed
description. Fixation tool 144 incorporates staple push rod 130 and
is useful in delivering staple 100. FIG. 10A and FIG. 10B may be
referred to collectively as FIG. 10. It is customary to refer to
multi-view projections using terms such as front view, top view,
and side view. In accordance with this convention, FIG. 10A may be
referred to as a top view of fixation tool 144 and FIG. 10B may be
referred to as a side view of fixation tool 144. The terms top view
and side view are used herein as a convenient method for
differentiating between the views shown in FIG. 10. It will be
appreciated that the elements shown in FIG. 10 may assume various
orientations without deviating from the spirit and scope of this
detailed description. Accordingly, the terms top view and side view
should not be interpreted to limit the scope of the invention
recited in the attached claims.
In the embodiment of FIG. 10, fixation tool 144 comprises a
fixation tool shaft 146 that is attached to a handle 148. Fixation
tool shaft 146 comprises a wall 150 defining a lumen 152. With
reference to FIG. 10, it will be appreciated that fixation tool
shaft 146 includes a first prong 154A and a second prong 156B that
extend distally beyond a distal end 158 of lumen 152.
In FIG. 10, a staple 100 can be seen residing in lumen 152 of
fixation tool shaft 146. For purposes of illustration, a distal
portion of fixation tool shaft 146 is enlarged in FIG. 10 to better
show staple 100. Staple 100 comprises a first arm 102A, a second
arm 102B, and a bridge 104 extending from the proximal end of first
arm 102A to the proximal end of second arm 102B. The distal end of
first arm 102A abuts the proximal end of a first fluke 106A.
Similarly, the distal end of second arm 102B abuts the proximal end
of a second fluke 106B. In FIG. 10, first fluke 106A and second
fluke 106B are shown extending distally from first arm 102A and
second arm 102B, respectively.
Staple push rod 130 includes a shaft 132 and a pair of stakes 134
extending distally beyond a distal end of shaft 132. The distal
direction is indicated with an arrow D in FIG. 10. Stakes 134
include a first stake 134A and a second stake 134B. In FIG. 10, a
distal portion of each stake 134 can be seen extending through a
passageway defined by staple 100. In the embodiment of FIG. 10, a
trigger 160 is pivotably coupled to handle 148 of fixation tool
144. Trigger 160 is operatively coupled to staple push rod 130. In
operation, staple push rod 130 will be advanced and/or retracted in
an axial direction when trigger 160 is pivoted relative to handle
148.
FIG. 11A is a further enlarged top view of a distal portion of
fixation tool shaft 146 shown in the previous Figure. For purposes
of illustration, fixation tool shaft 146 is shown in partial
cross-section in FIG. 11A so that staple 100 is visible residing in
lumen 152. With reference to FIG. 11A, it will be appreciated that
staple 100 is disposed on a distal portion of staple push rod 130.
Staple 100 comprises a first arm 102A, a second arm 102B, and a
bridge 104 extending from the proximal end of first arm 102A to the
proximal end of second arm 102B. The distal end of first arm 102A
abuts the proximal end of a first fluke 106A. Similarly, the distal
end of second arm 102B abuts the proximal end of a second fluke
106B. In FIG. 11, first fluke 106A and second fluke 106B are shown
extending distally from first arm 102A and second arm 102B,
respectively.
First fluke 106A of staple 100 defines a first passageway 124A. In
FIG. 11A, a distal portion 138 of first stake 134A of staple push
rod 130 can be seen extending through first passageway 124A defined
by first fluke 106A. A distal portion 138 of second stake 134B of
staple push rod 130 can be seen extending through a second
passageway 124B defined by second fluke 106B of staple 100.
In FIG. 11A, a first shoulder 142A of first stake 134A is shown
contacting proximal surface 108 of first fluke. Distal portion 138
of first stake 134A extends distally of first shoulder 142A and
proximal portion 140 of first stake 134A extends proximally of
first shoulder 142A. In some useful embodiments, the proximal
portion of first stake 134A has a first thickness and the distal
portion of first stake 134A has a second thickness different from
the first thickness. In some particularly useful embodiments, the
second thickness is less than the first thickness. In some
applications, this may increase the flexibility of the distal
portion of first stake 134A so that it bends more easily, and so
that it withdraws from the staple with minimal force.
A second shoulder 142B of second stake 134B is shown contacting
proximal surface 108 of second fluke 106 in FIG. 11A. A distal
portion 138 of second stake 134B extends distally of second
shoulder 142B and a proximal portion 140 of second stake 134B
extends proximally of second shoulder 142B. In some useful
embodiments, the proximal portion of second stake 134B has a first
thickness and the distal portion of second stake 134B has a second
thickness different from the first thickness. In some particularly
useful embodiments, the second thickness is less than the first
thickness. In some applications, this may increase the flexibility
of the distal portion of first stake 134A so that it bends more
easily, and so that it withdraws from the staple with minimal
force.
With reference to FIG. 11A, it will be appreciated that there is a
gap G between staple push rod 130 and bridge 104 of staple 100. In
some applications, gap G allows staple 100 to be placed in tension
without bridge 104 contacting staple push rod 130. Staple 100 may
be placed in tension, for example, as staple 100 is advanced into a
target tissue.
FIG. 11B is an additional top view showing a distal portion of
fixation tool shaft 146, staple push rod 130, and staple 100. By
comparing FIG. 11A and FIG. 11B, it will be appreciated that staple
push rod 130 and staple 100 have been advanced in a distal
direction D relative to fixation tool shaft 146. In FIG. 11B,
staple 100 is shown extending out of lumen 152 defined by fixation
tool shaft 146.
In FIG. 11B, a distal portion 138 of first stake 134A of staple
push rod 130 can be seen extending through a first passageway 124A
defined by first fluke 106A of staple 100. In FIG. 11B, a first
shoulder 142A of first stake 134A is shown contacting proximal
surface 108 of first fluke 106A. Distal portion 138 of first stake
134A extends distally of first shoulder 142A and proximal portion
140 of first stake 134A extends proximally of first shoulder 142A.
In some useful embodiments, the proximal portion of first stake
134A has a first width and the distal portion of first stake 134A
has a second width different from the first width. In some
particularly useful embodiments, the first width is greater than
the first width. The arrangement allows the proximal portion of
stake to engage a proximal surface of the staple to apply pushing
forces to the staple.
In FIG. 11B, a distal portion 138 of second stake 134B of staple
push rod 130 can be seen extending through a second passageway 124B
defined by second fluke 106B of staple 100. In FIG. 11B, a second
shoulder 142B of second stake 134B is shown contacting proximal
surface 108 of second fluke 106B. In the embodiment of FIG. 11B,
proximal portion 140 of second stake 134B may apply pushing force
to proximal surface 108 of second stake 134B. Proximal portion 140
of second stake 134B extends proximally of second shoulder 142B and
distal portion 138 of second stake 134B extends distally of second
shoulder 142B. In the embodiment of FIG. 11B, proximal portion 140
of second stake 134B has a width larger than the width of distal
portion 138 of second stake 134B so that the shoulder 142 of second
stake 134B contacts proximal surface 108 of second fluke 106B to
apply pushing forces thereto.
In the embodiment of FIG. 11B, first stake 134A and second stake
134B are in a substantially unstressed state. It will be
appreciated that first stake 134A and second stake 134B can be
resiliently urged to assume shapes other than the shape shown in
FIG. 11. For example, first stake 134A and second stake 134B may be
urged together so that fork 136 of staple push rod 130 and staple
100 can be inserted into lumen 152 defined by fixation tool shaft
146.
With reference to FIG. 11B, it will be appreciated that there is a
gap G between staple push rod 130 and bridge 104 of staple 100. In
some applications, gap G allows staple 100 to be placed in tension
without bridge 104 contacting staple push rod 130. In some
applications, placing staple 100 under tension may urge first fluke
106 and second fluke 106 into orientations which lock staple 100
into a target tissue. For example, first fluke 106A and second
fluke 106B may be rotated so that a barb of each fluke engages the
target tissue. When this is the case, the tension on the staple may
keep first fluke 106A and second fluke 106B in the rotated
position. Also when this is the case, the barbs of the rotated
flukes may inhibit staple pullout.
FIG. 12A through FIG. 12C are a sequence of plan views illustrating
an exemplary method in accordance with the present detailed
description. FIG. 12A, FIG. 12B, and FIG. 12C may be collectively
referred to as FIG. 12. The exemplary method illustrated in FIG. 12
may be used, for example, to fix a tendon repair implant 50 to a
target tissue T using a staple 100.
At FIG. 12A, a fixation tool 144 has been used to form a first
pilot hole 162A and a second pilot hole 162B in target tissue T. In
the embodiment of FIG. 12, fixation tool 144 includes a fixation
tool shaft 146 comprising a wall 150 defining a lumen 152. With
reference to FIG. 12, it will be appreciated that fixation tool
shaft 146 includes a first prong 154A and a second prong 156B that
extend distally beyond a distal end 158 of lumen 152. In the
embodiment of FIG. 12A, first prong 154A and second prong 156B have
been urged into tissue T to form first pilot hole 162A and second
pilot hole 162B. In FIG. 12A a distally directed force applied to
fixation tool shaft 146 is illustrated using an arrow. Force F may
be produced, for example, by pushing on a handle that is fixed to a
proximal portion of fixation tool shaft 146. It will be appreciated
that in some embodiments, such as the embodiment depicted in FIG.
6, one of the first and second pilot holes may be formed through
the sheet-like implant and the target tissue, and the other pilot
hole may be formed directly in the target tissue without passing
through the sheet-like implant. In other words, in various
embodiments staples may straddle the perimeter edge of the
sheet-like implant (as shown in FIG. 6), may be applied adjacent to
the perimeter, and/or be applied to a central region of the
implant. In some embodiments, the staples may be used to attach the
implant to soft tissue and/or to bone. In FIG. 12A, a staple 100
can be seen residing in lumen 152 of fixation tool shaft 146. For
purposes of illustration, fixation tool shaft 146 is shown in
partial cross-section in FIG. 12A so that staple 100 is visible
residing in lumen 152. With reference to FIG. 12, it will be
appreciated that staple 100 is carried by a fork 136 comprising a
first stake 134A and a second stake 134B. In FIG. 12A, a distal
portion of first stake 134A of staple push rod 130 can be seen
extending through a first passageway defined by first fluke 106A. A
distal portion of second stake 134B of staple push rod 130 can be
seen extending through a second passageway defined by second fluke
106B of staple 100.
In some useful embodiments, each stake is positioned relative to a
prong along an inner surface of fixation tool shaft 146 so that the
stakes advance into the pilot holes when the stakes are moved in a
distal direction. Staple push rod 130 is slidably disposed within
lumen 152 defined by along fixation tool shaft 146. Fixation tool
144 includes a mechanism that is capable of creating relative axial
motion between staple push rod 130 and fixation tool shaft 146 so
that staple push rod 130 slides along fixation tool shaft 146.
At FIG. 12B, relative motion has been created between staple push
rod 130 and fixation tool shaft 146 while distally directed force F
has been continuously applied to fixation tool shaft 146. By
comparing FIG. 12B and FIG. 12A, it will be appreciated that first
stake 134A and second stake 134B have been advanced in a distal
direction D. With reference to FIG. 12, it will also be appreciated
that first stake 134A and second stake 134B have advanced into
first pilot hole 162A and second pilot hole 162B, respectively. In
FIG. 12B, first fluke 106A is shown residing in first pilot hole
162. Second fluke 106B is residing in second pilot hole 162 in the
embodiment of FIG. 12B.
At FIG. 12C, additional relative motion has been created between
staple push rod 130 and fixation tool shaft 146 while distally
directed force F has been continuously applied to fixation tool
shaft 146. By comparing FIG. 12C and FIG. 12B, it will be
appreciated that the relative motion between staple push rod 130
and fixation tool shaft 146 has moved fixation tool shaft 146 in a
proximal direction P.
By comparing FIG. 12C and FIG. 12B, it will also be appreciated
that first arm 102A of staple 100 has been bent and first fluke
106A has been rotated to a toggled position. In the exemplary
embodiment of FIG. 12C, force applied to first fluke 106A by first
shoulder 142A has caused first fluke 106A to rotate. Also in the
embodiment of FIG. 12C, the rotation of first fluke 106A has caused
some bending in the distal portion 138 of first stake 134A. With
continuing reference to FIG. 12C and FIG. 12B, it will be
appreciated that second arm 102B of staple 100 has been bent and
second fluke 106A has been rotated to a toggled position. In the
exemplary embodiment of FIG. 12C, force applied to second fluke
106b by second shoulder 142B has caused second fluke 106B to
rotate. Also in the embodiment of FIG. 12C, the rotation of second
fluke 106B has caused some bending in the distal portion 138 of
second stake 134B.
With reference to FIG. 12C, it will be appreciated that a first
through hole 164A and a second through hole 164B have been formed
in tendon repair implant 50. In the embodiment of FIG. 12, first
through hole 164A and a second through hole 164B were created by
urging first prong 154A and second prong 156B of fixation tool
shaft 146 through tendon repair implant 50.
FIG. 13A, FIG. 13B, and FIG. 13C are multiview projections
illustrating a fixation tool shaft 146 shown in the previous
Figures. FIG. 13D is a cross-sectional view of fixation tool shaft
146 sectioned along cutting plane D-D illustrated in FIG. 13C.
These Figures may be collectively referred to as FIG. 13. Fixation
tool shaft 146 of FIG. 13 comprises a wall 150 defining a lumen
152. A first prong 154A and a second prong 156B of fixation tool
shaft 146 extend distally beyond a distal end 158 of lumen 152.
With reference to FIG. 13, it will be appreciated that fixation
tool shaft 146 comprises a proximal portion 170, a distal portion
168 and an intermediate portion 166 disposed between proximal
portion 170 and distal portion 168. In the embodiment of FIG. 13,
distal portion 168 has an axial extent DA, a major lateral extent
LA and a minor lateral extent LB. With reference to FIG. 13, it
will be appreciated that axial extent DA is greater than both minor
lateral extent LB and major lateral extent LA.
FIG. 14 is an enlarged axial view of fixation tool shaft 146 shown
in the previous Figure. With reference to FIG. 14, it will be
appreciated that proximal portion 170 of fixation tool shaft 146
comprises a wall 150 having an outer surface 172. In FIG. 14, outer
surface 172 is illustrated using a circle. Thus, it will be
appreciated that proximal portion 170 of fixation tool shaft 146
has a generally cylindrical outer shape in the exemplary embodiment
of FIG. 14. In the exemplary embodiment of FIG. 14, fixation tool
shaft 146 has a generally uniform wall thickness. Accordingly, the
shape of proximal portion 170 may be generally described as a
cylindrical tube. The shape of distal portion 168 may be described
as a cylindrical-tube that has been partially flattened. In the
exemplary embodiment of FIG. 14, distal portion 168 of fixation
tool shaft 146 has a major lateral extent LA and a minor lateral
extent LB. With reference to FIG. 14, it will be appreciated that
major lateral extent LA is greater than minor lateral extent
LB.
FIG. 15 is an additional enlarged axial view of fixation tool shaft
146. With reference to FIG. 15, it will be appreciated that distal
portion 168 of fixation tool shaft 146 comprises a first major side
SA, a second major side SB, a first minor side SC, and a second
minor side SD. In the exemplary embodiment of FIG. 15, each minor
side has a first central radius RA and each major side has a second
central radius RB. With reference to FIG. 15, it will be
appreciated that second central radius RB is greater than first
central radius RA. In the exemplary embodiment of FIG. 15, first
major side SA, second major side SB, first minor side SC, and
second minor side SD each have a generally convex shape. In the
exemplary embodiment of FIG. 15, each minor side is generally more
convex than each major side.
FIG. 16 is an exploded isometric view of an exemplary fixation tool
144 in accordance with this detailed description. In the embodiment
of FIG. 16, fixation tool 144 comprises a fixation tool shaft 146
and a handle 148. In FIG. 16, handle 148 is exploded into two
pieces. A proximal portion of fixation tool shaft 146 is fixed to
handle 148 when fixation tool 144 is in an assembled state.
Fixation tool shaft 146 comprises a wall 150 defining a lumen 152.
With reference to FIG. 16, it will be appreciated that fixation
tool shaft 146 includes a first prong 154A and a second prong 156B
that extend distally beyond a distal end 158 of lumen 152.
When fixation tool 144 is in an assembled state a staple push rod
130 extends into lumen 152 of fixation tool shaft 146. Staple push
rod 130 comprises a fork 136 and a shaft 132. Fork 136 comprises a
first stake 134A and a second stake 134B. Shaft 132 is coupled
between fork 136 and a lever 174. Lever 174 is coupled to a trigger
160. Trigger 160 is pivotably coupled to handle 148 of fixation
tool 144 when fixation tool 144 is in an assembled state. In
operation, staple push rod 130 will be advanced and/or retracted in
an axial direction when trigger 160 is pivoted relative to handle
148.
While exemplary embodiments of the present invention have been
shown and described, modifications may be made, and it is therefore
intended in the appended claims and subsequently filed claims to
cover all such changes and modifications which fall within the true
spirit and scope of the invention.
* * * * *
References